Policies & Legislation

US Senate approves patent reform

Home/Policies & Legislation | Posted 16/09/2011

On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.

European Commission publishes new rules on falsified medicines

Home/Policies & Legislation | Posted 26/08/2011

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.

Effect of patent filing and initiation of clinical trials on market exclusivity

Home/Policies & Legislation | Posted 05/08/2011

The effect of the date of patent filing and the initiation of clinical trials can influence the expected duration of marketing exclusivity for originator companies.

Concerns of patent filing and approval date on market exclusivity

Home/Policies & Legislation | Posted 29/07/2011

An understanding of the relationship between the date of patent filing and the marketing approval date on the expected duration of marketing exclusivity is critical for originator companies to maximise this period of exclusivity in order to recuperate their research and development costs before the advent of generic competition. Recent research has modelled the available duration of US market exclusivity for originator drugs at various times after the initial patent filing [1].

Patent filing and market exclusivity

Home/Policies & Legislation | Posted 08/07/2011

The relationship between patent filing dates and the marketing authorisation date can change the duration of marketing exclusivity an originator pharmaceutical product can expect to enjoy [1].

Italy and Spain threaten legal action over EU patent

Home/Policies & Legislation | Posted 01/07/2011

EU ministers have adopted a general approach to the two Commission proposals that provide for a European patent to protect inventions in the same way in all participating member countries. However, Italy and Spain are objecting to the ‘enhanced cooperation’ procedure and threatening legal action.

US caucus to promote generics and biosimilars

Home/Policies & Legislation | Posted 27/05/2011

Two House members have established a group that they hope will produce legislation that leads to increased use of generic and biosimilar drugs and lower healthcare costs.

UK’s NICE issues first biosimilar recommendation

Home/Policies & Legislation | Posted 29/10/2010

In a report published in May 2010 the UK’s National Institute for Health and Clinical Excellence (NICE) issued its first biosimilar recommendation, saying the biosimilar somatropin offers the same efficacy and safety as originator somatropins.

US patent reform legislation may delay generics

Home/Policies & Legislation | Posted 06/05/2011

Generic drugmakers have been dealt a blow in Congress now that the Senate has passed patent-reform legislation despite efforts by the generics industry to remove a provision in the bill.

2012’s biggest patent expiries

Home/Policies & Legislation | Posted 29/04/2011

Once the patent expiries set for 2011 are gone it is not over for the pharmaceutical industry, as 2012 looks set to be another bumper year for generics, with patents from more of the biggest selling drugs set to expire.